Carbon fiber orthosis and associated method

ABSTRACT

A method of making an orthoses, comprising the steps of preparing a plaster mold, upon which the layers of the orthosis will be placed and formed; and placing layers of material on the mold, then forming and removing the layers. An orthosis, comprising a footplate that is capable of receiving a human foot thereabove, a heel portion at the rear side of the footplate; a strut extending upwardly from the heel portion; a calf portion extending forwardly from the strut, the calf portion including a tibial shell; the tibial shell extends around the front of the user&#39;s tibia; a rear portion extends around the back of the user&#39;s calf a rear portion disposed rearwardly with respect to the calf portion; and sides such that the calf portion is completely circumferential without seams. Two foam layers line the orthoses for comfort and ease of use.

RELATED APPLICATIONS

This application claims priority from U.S. provisional patentapplication No. 60/942,446, filed on Jun. 6, 2007.

BACKGROUND OF THE INVENTION

The present invention is directed to a method of making an orthoses(i.e., devices which support or correct the function of a limb or thetorso), and more particularly to a carbon fiber ankle-foot orthosis, ororthotic, and to the structure of the orthosis.

In traditional Ankle Foot Orthotics (known in the art as “AFOs”), orKnee-Ankle Foot Orthotics (“KAFOs”) the patient's ankle is usually fixedat 90 degrees by a thermoplastic or metal and leather AFO or KAFO toprovide adequate clearance in swing phase of gait. In some cases, wherethe patient demonstrates active movement against gravity in the ankle,the traditional brace can only give dorsiflexion assist and can onlyassist or resist in one direction.

One particular disadvantage of these conventional AFO's is that patientsmay lose their active range of motion and/or lose all potential to gainactive range of motion, if they do not move a muscle or joint for anextended period of time. By not moving in a natural pattern repetitivedamage may occur to joints further up the chain. If the orthosis couldallow for movement, assist/resist in both dorsiflexion and plantarflexion of the ankle at the same time a natural gait pattern could beproduced similar to a non-affected limb.

SUMMARY OF THE INVENTION

The present invention provides a carbon fiber orthosis that enablesnatural movement to the foot, ankle, knee and hip during gait. Theorthosis provides both dorsiflexion and plantar flexion assist of theankle at the same time.

In one embodiment, the orthosis is an ankle-foot orthosis that includesat least one layer of carbon fiber that is impregnated with a resin andhardened into the shape of a desired limb or body part. In oneembodiment, the orthosis includes a plurality of layers of carbon fiberfabric and a structural enhancer, such as a layer of braided carbonfiber tubing that is attached to the carbon fiber fabric. The braidedcarbon fiber tubing may be attached to the carbon fiber fabric by one ormore layers of resin placed between the braided carbon fiber tubing andthe carbon fiber fabric.

In another embodiment the orthosis includes a first layer of impregnatedcarbon fiber fabric, a second layer of impregnated carbon fiber fabric,a third layer of impregnated carbon fiber fabric, a layer of braidedcarbon fiber tubing adhered to the third layer of fabric, a fourth layerof impregnated carbon fiber fabric adhered to the braided carbon fibertubing and the third layer of fabric, and a fifth layer of impregnatedcarbon fiber fabric. The layers of carbon fiber fabric may be either aunidirectional weave or a bidirectional weave, and in one embodiment,the layers alternate between unidirectional and bidirectional.

The orthosis is designed to be used most commonly with neuromusculardiseases to assist the musculoskeletal system in recreating what ismissing from the nervous system.

In one embodiment, the types of pathologies that the orthosis is mostcommonly designed for are: Charcot-Marie-Tooth Neuropathy, MultipleSclerosis, ALS, Traumatic Brain Injury, CVA with hemiparisis, PeripheralNeuropathies, Spinal Cord Injury, Cerebral Palsy, Spinal Bifida, FootDrop, Weakness in Quadriceps, etc. In another embodiment, anyone with aNeuromuscular Condition that decreases function in the lower extremitiescan be a candidate for this new orthosis. Typically, if the patient hasa grade 2 or less dorsiflexion strength the orthosis will fix the ankleat 90 degrees. The present invention allows for movement and actuallyassists and resists dorsiflexion and plantar flexion. If the patient hasany deficits in proprioception and or strength in dorsiflexion, plantarflexion or quadriceps the present invention will provide the appropriateamount of support and still allow for a normal heel to toe progression.Since the present invention is custom molded and provides total contactwherever the carbon is located, it gives increased proprioception andcorrection of a joint (Ex. Foot and Ankle). The patient can have pesplanus, and subtalar valgus or pes cavus and subtalar varus and becorrected to neutral. The footplate is total contact and containsvarus/valgus corrective forces.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a pictorial of one embodiment of the present invention;

FIG. 1A is a pictorial of one embodiment of the present invention as itmay be applied to a lower leg;

FIG. 2 is a pictorial of a front view of an embodiment of the presentinvention;

FIG. 3 is a pictorial of a side view of an embodiment of the presentinvention;

FIG. 4 is a pictorial of a rear view of an embodiment of the presentinvention;

FIG. 5 is a pictorial of a top view of an embodiment of the presentinvention;

FIG. 6 is a pictorial of a an embodiment with the reinforcing foamillustrated;

FIG. 7 is a pictorial of an exploded view from FIG. 6, illustrating thestandard foam and the reinforcing foam.

FIG. 9 is a pictorial of an embodiment of the present invention with aknee member, to form a knee-ankle-foot orthotic (“KAFO”).

FIG. 10 is a block diagram of an embodiment of a method of making thepresent invention.

FIG. 11 is a block diagram of an embodiment of a method of making thepresent invention.

DETAILED DESCRIPTION OF THE CURRENT EMBODIMENT I. Overview

This invention is a method of making an ankle-foot orthotic (AFO)orthosis, and a knee-ankle-foot orthotic (KAFO) orthosis.

FIG. 1 illustrates one embodiment of the present invention orthosis 10.This invention is also the apparatus or structure generally designated10. Although the materials and associated method of the presentinvention could be used in connection with a wide variety of orthoses,for purposes of illustration, it will be described in connection withone embodiment, wherein the orthosis is an ankle-foot orthotic (AFO)orthosis 10. In another embodiment, the orthosis may be formed to fit amore extensive portion of a patient's leg that incorporates thepatient's knee, a knee-ankle-foot orthotic (KAFO) orthosis 10. In yetanother embodiment, the orthosis is formed to fit a completely separatefeature of the patient's anatomy, such as a patient's torso.

II. Structure

As illustrated in FIGS. 1-9, The ankle-foot orthosis 10 generallyincludes a calf portion 12, footplate 14 and a strut 16 connecting thecalf portion 12 and the footplate 14. In one embodiment, the entireorthosis 10 is molded to a shape that is customized to the particularshape of the leg of a particular user. The calf portion 12 includes atibial shell 18 that extends around the front of the user's tibia, arear portion 20 that extends around the back of the user's calf, andsides 22, 24 that extend along the sides of the user's leg, such thatthe calf portion is completely circumferential without seams. Thefootplate 14 extends under substantially all of the foot of the user,and includes lateral 26 and medial 28 flanges that extend upwardly onthe sides of the user's foot, and a heel portion 30 that extendsupwardly around the heel of the user's foot. The strut 16 extendsbetween the calf portion 12 and the footplate 14. In the illustratedembodiment, the strut 16 is a generally straight strip of material thatconnects the heel portion 20 of the footplate 14 to the sides 22, 24 ofthe calf portion 12.

FIG. 7 illustrates an embodiment having two levels of varying foam. Astandard foam 72 is nearest the leg of the user, which the user's skinmay contact and is more pliable and softer than the reinforcing foam 70.The reinforcing foam 70 enables the standard foam 72 to flex and move,without hitting a hard firm surface, which would cause the user pain anddiscomfort. The reinforcing foam 70 may be applied to the carbon fibermaterial, and the standard foam 72 may be applied to the reinforcingfoam 70 via an adhesive. The standard foam 72 disposed in thecontactable area, which is an area where the user's skin or leg maycontact the orthoses, so that the user's skin contacts the standard foam72 during use, and a reinforcing foam 70 disposed between the standardfoam 72 and at least one of said footplate 14, said heel portion 30,said strut 16, said heel portion 30, said calf portion 12, or saidtibial shell 18.

FIG. 9 illustrates a knee-ankle-foot orthosis (KAFO), which isessentially the AFO of the present invention, with the knee member 50movably connected to the AFO of the present invention via a movablejoint 52.

In one embodiment, the entire orthosis is formed from a layer or layersof hardened carbon, graphite or Kevlar fiber fabric, such as a wovencarbon fiber fabric that is pre-impregnated with an epoxy resin andhardened on a mold in an oven. The carbon fiber fabric may be abidirectional weave, a unidirectional weave, or an alternative weave orarrangement. One example of a bidirectional weave may be a typemanufactured by Mapewrap, and called MAPEWRAP C BI-AX. One type ofunidirectional weave may be a type manufactured by Mapewrap, and calledMAPEWRAP C UNI-AX. These types of products may be found athttp://www.directindustry.com/prod/mapei/carbon-fiber-33942-197584.html.In embodiments that include multiple layers of the pre-impregnatedfabric, the resin of the various layers is bonded together during aheating process under intense vacuum. The orthosis 10 may furtherinclude a layer or layers of carbon, graphite or Kevlar fibers in abraided tubular form 50, referred to as a “g-braid.” The g-braid usedmay have one of a variety of widths, ranging from about ⅜″ to about 6″.In one embodiment, the orthosis additionally includes a layer or layersof resin sheets 60, often referred to as “ready preg,” that arecomprised of a hardened sheet of an epoxy resin. The ready preg sheetsmay be placed, for example, above and below the layers of g-braid, suchthat the ready preg flows into and through the g-braid during theheating and curing process to attach the g-braid to the other layers. Inone embodiment, a sheet of ready preg is rolled up and inserted into ag-braid tube to provide an additional bond between the layers. Thesheets of ready preg are typically frozen sheets that are melted intothe fabric layers when the orthosis is heated.

In the illustrated embodiment, the orthosis 10 includes a particulararrangement of the above noted materials, including a first layer ofbidirectional pre-impregnated carbon fiber fabric on the calf portion12, strut 16 and footplate 14; a second layer of unidirectionalpre-impregnated carbon fiber fabric on the calf portion 12, strut 16 andfootplate 14; a third layer of bidirectional pre-impregnated carbonfiber fabric located only on the strut; a layer of ready preg on thecalf portion 12, strut 16, and footplate 14; a layer of 1″ g-braid onthe calf portion 12 and the strut 16; a layer of g-braid on the strut16, around the footplate 14 and up to the back of the calf portion 12,with a sheet of ready preg inserted into the g-braid tube on the strut16; a layer of ready preg over all of the g-braid; a fourth layer ofunidirectional pre-impregnated carbon fiber fabric on the strut 16 only;and a fifth layer of bidirectional pre-impregnated carbon fiber fabricon the calf portion 12, strut 16 and footplate 14.

The arrangement and layering of the orthosis materials of the presentinvention is important in this orthosis due to the carbon fiber springthat is fabricated. In a sense the strut 16—or posteriorbeam—effectively forms a large spring. The spring has to have enoughstrength not to break, but yet enough flexibility to allow naturalmovement. This is achieved by adding more or less layers dependent uponthe patient's height, weight, and strength. In one embodiment, theorthosis is fabricated with a beam that is stronger than needed, andtrimmed narrower to make it more flexible as desired. This makes thestrut adjustable even though it does not incorporate ankle joints.

III. Method of Manufacture

An orthosis according to one embodiment of the present invention ismanufactured using the following steps, which are broken down into twosections. First, preparing a plaster mold 80, upon which the layers ofthe orthosis will be placed and formed. Second, placing layers ofmaterial on the mold, then forming and removing the layers.

Preparation of the Plaster Mold

This step 80, which may include preparing the plaster mold 80, may havethe following steps:

-   -   1. Creating a molded plaster or fiberglass cast 100.        -   Creating a molded plaster or fiberglass cast 100 is            performed by creating a molded plaster or fiberglass cast 70            in the shape of the feature of the patient's anatomy upon            which the orthosis is intended to be used. In one            embodiment, this may be applicable to the lower portion of a            patient's leg, including the ankle and the foot.    -   2. Stapling and sealing the cast with plaster bandage 110.    -   3. Setting the cast such that the angle between the foot portion        and the leg portion is approximately 90 degrees (depending upon        heel height of shoe) 120.    -   4. Sealing the cuts in the cast with the cast angled at about 90        degrees 130.    -   5. Filling the cast with plaster, and then allowing the plaster        mold to set 140.    -   6. Stripping the initial cast away from the newly formed plaster        mold 150.    -   7. Smoothing the plaster mold with sheer forms and a sanding        screen 160.    -   8. Marking the finish height and heights for back of the        orthosis directly on the plaster mold 170.    -   9. Drawing trim lines indication the dimensions of the orthosis        directly on the plaster mold 180. In one embodiment, the front        tibia shell (i.e., the calf portion 12 of the orthosis that        extends around the front of the tibia) should be 3.5″ to 4″, the        sides of orthosis should be about 3.5″ wide, and the strut is        about 2″ wide.    -   10. Laying plaster bandage on the drawn trim line 190. This may        build up the mold at the areas near the trim lines-resulting in        flared edges in the final orthosis.    -   11. Applying liquid plaster on the plaster bandage 200 to make        all holes and valleys level.    -   12. Squaring off the portions of the mold in the area of the        footplate and build up the portions of the mold in the area of        the medical wall of the orthosis and the lateral wall of the        orthosis 210.    -   13. Sanding the entire mold 220 so that it is smooth and        everything has a smooth transition.    -   14. Recasting the modified leg mold 230 by pulling a cotton        stockinet or similar material over the leg, then wrap leg with        fiberglass wrap, let the wrap harden, then cut the wrap off of        the leg mold.    -   15. Heating and pulling a foam padding material over the calf        portion of the leg mold and affixing the foam to the mold 240.    -   16. Cutting the foam away from the strut 250, so that it doesn't        cover any part of the strut.    -   17. Skiving the foam so that it tapers down to the plaster mold,        and then skiving the foam in the area of the footplate 260        before pulling it on the plaster mold.    -   18. Heating the foam in the area of the footplate and pull the        heated foam over the foot plate, affixing or stapling the foam        to the footplate 270.    -   19. Wrapping a clear plastic wrap (such as conventional kitchen        plastic wrap) over the entire orthosis, including over the foam        280.    -   20. Tracing the trim lines drawn on the mold onto a material        that is placed on the mold 290, such as a piece of paper, to        create a pattern that can be used to cut layers of the orthosis        to appropriate sizes. This will ensure the necessary amount of        material is used in creating the orthosis, minimizing waste.

Lay Up of the Materials Forming the Orthosis

This step 90 may include placing layers of material on the mold, thenforming and removing the layers described below.

-   -   1. Applying a layer of bidirectional carbon fiber fabric over        the calf, strut and footplate areas of the mold 300, and over        the foam. The layer of carbon fiber fabric may be        pre-impregnated with resin.    -   2. Placing a layer of unidirectional carbon fiber fabric over        the calf, strut and footplate 310. The layer of carbon fiber        fabric may be impregnated with resin.    -   3. Applying a layer of bidirectional carbon fiber fabric in the        strut 320. When included, this layer may increase the strength        of the strut, and enhance the assist characteristics of the        orthosis for both dorsiflexion and plantar flexion. The layer of        carbon fiber fabric may be impregnated with resin.    -   4. Placing a sheet of resin material 102, such as Ready Preg,        around the calf, down the strut and around the footplate 330.    -   5. Applying a 1″ g-braid (a braided, tubular carbon fiber        fabric) around the calf and cut at the strut 340.    -   6. Placing a 1″ g-braid 108 down the strut, around the        footplate, and back up to the back of the calf 350. When the        g-braid in steps 5 and 6 is included, it may increase the        strength of the orthosis in the areas that it is placed, and        enhance the assist characteristics of the orthosis for both        dorsiflexion and plantar flexion.    -   7. Sliding a sheet of resin down inside the tubular g-braid on        the strut only 360.    -   8. Applying a sheet of resin 110 over all exposed g-braid 370,        making sure that all of the g-braid is covered, or at least that        most of the g-braid is covered.    -   9. Placing a layer of bidirectional carbon fiber fabric over the        calf, strut and footplate 380. The layer of carbon fiber fabric        may be impregnated with resin.    -   10. Applying a layer of bidirectional carbon fiber fabric over        the calf, strut and footplate 390. The layer of carbon fiber        fabric may be impregnated with resin.    -   11. Wrapping the orthosis with clear plastic wrap about 3 to 6        times 400.    -   12. Creating holes through the plastic wrap along the G-braid in        the calf, strut and footplate 410.    -   13. Pulling a shear nylon stockinet over entire leg twice 420.    -   14. Pulling a thicker (thicker than the shear nylon stockinet in        step 420) nylon stockinet over entire leg twice 430.    -   15. Moving leg to roto lam rack and pull a plastic bag over the        leg, sealing it so that it is air tight 440.    -   16. Placing the wrapped leg into a vacuum chamber oven 200, and        turn on the vacuum, making sure that there is no air leaks 450.    -   17. Heating orthosis for approximately 4 hours at about 250° F.        460.    -   18. Testing orthosis by applying pressure, such as with thumb to        make sure that orthosis is done and there are no soft spots 470.    -   19. Pulling orthosis out of oven pulling all layers of plastic        and nylon stocking off of orthosis 480.    -   20. Breaking orthosis off of the plaster mold 490.    -   21. Smoothing or sanding orthosis down to the trim lines and        rough up the outside surface 500.    -   22. Cleaning off all extra dust and materials with water 510.    -   23. Mixing two-part epoxy at about a 1 to 1 ration 520.    -   24. Applying epoxy to clean orthosis let stand for about 24        hours 530.    -   25. Sanding down all extra epoxy 540.    -   26. Cutting out pads out of foam for the calf and footplate 550.    -   27. Skiving calf edges and footplate next to the heel 560.    -   28. Sanding down all edges so that foam and carbon are level or        flush 570.    -   29. Attaching a strap to the back of the calf 580.

The above method of manufacture is used in the formation of oneembodiment of the present invention, wherein the orthosis includes fivelayers of carbon fiber fabric. This embodiment has been proven throughtesting to provide a high degree of strength, and very low weight, suchthat it is useful for a wide range of patient types. Alternativeembodiments of the present invention are possible, and may vary thenumber of layers, the particular arrangement of bidirectional andunidirectional layers and the use and location of the g-braid and thesheets of resin. The use of additional layers of carbon—either in fabricsheet form or braided form—increases the strength of the orthosis in theareas where the additional carbon is placed. The use of additionallayers of resin sheets increases the bond between the various layers ofcarbon, especially in the specific areas in which in the resin sheetsare placed. In embodiments where the carbon fiber fabric or g-braid ispre-impregnated with resin, the resin sheets also bond with theimpregnated resin during the heating process. In an alternativeembodiment, wherein the carbon fiber fabric is not pre-impregnated withresin, sheets of resin may be placed between each layer of carbon fiberfabric to attach the layers together. In another alternative embodiment,the layers may be attached by another known method, such as wetlamination.

The variations in layers of carbon, g-braid, and adhesive in the area ofthe strut are generally determined by starting with the embodiment notedin the above method (i.e., 5 layers of pre-impregnated carbon fiber,arranged bi-uni-bi-uni-bi, with one g-braid down the center of thestrut, including a sheet of resin inside the g-braid). This is base linefrom for 50 lbs and 42 inches tall to 165 lbs and 5 foot ten inches. Asthe need arises to add layers for activity levels and height and weightit is imperative that the clinician evaluates through gait analysisforces to determine if more layers are required. (Example: golfing addsmore stress to the spring of carbon fiber and requires morereinforcement). In one embodiment, if the patient is greater than 165lbs and 5″10, another layer of g-braid is inserted inside of theoriginal braid (a tube within a tube) and add more resin (typicallyready-preg resin). In another embodiment, if additional reinforcement isneeded, one more layer of uni and one more layer of bi may be added,making the orthosis 7 layers of carbon fiber fabric and 2 layers ofg-braid. This embodiment is suitable for patients up to 300 lbs., and6′7″ tall.

The above descriptions are those of current embodiments of theinvention. Various alterations and changes can be made without departingfrom the spirit and broader aspects of the invention.

1. A method of making a orthoses, comprising the steps of: preparing aplaster mold 80, upon which the layers of the orthosis will be placedand formed; and placing layers of material on the mold, then forming andremoving the layers
 90. 2. The method of claim 1, wherein the step ofpreparing a plaster mold 80, further comprises: creating a moldedplaster or fiberglass cast 100; stapling and sealing the cast withplaster bandage 110; setting the cast such that the angle between thefoot portion and the leg portion is approximately 90 degrees 120;sealing the cuts in the cast with the cast angled at about 90 degrees130; filling the cast with plaster, and then allowing the plaster moldto set 140; stripping the initial cast away from the newly formedplaster mold 150; smoothing the plaster mold with sheer forms and asanding screen 160; marking the finish height and heights for back ofthe orthosis directly on the plaster mold 170; drawing trim linesindicating the dimensions of the orthosis directly on the plaster mold180; applying liquid plaster on the plaster bandage 200; squaring offthe portions of the mold in the area of the footplate and build up theportions of the mold in the area of the medical wall of the orthosis andthe lateral wall of the orthosis 210; sanding the entire mold 220 sothat it is smooth and everything has a smooth transition; recasting themodified leg mold 230: heating and pulling a foam padding material overthe calf portion of the leg mold and affixing the foam to the mold 240;cutting the foam away from the strut 250; skiving the foam so that ittapers down to the plaster mold, and then skiving the foam in the areaof the footplate before pulling it on the plaster mold 260; heating thefoam in the area of the footplate and pull the heated foam over the footand plate, affixing or stapling the foam to the footplate 270; wrappinga clear plastic wrap over the orthosis, including over the foam 280; andtracing the trim lines drawn on the mold onto a material that is placedon the mold 290;
 3. The method of claim 1, wherein the step of placinglayers of material on the mold, then forming and removing the layers 90,further comprises: applying a layer of bidirectional carbon fiber fabricover the calf, strut and footplate areas of the mold and over the foam300; placing a layer of unidirectional carbon fiber fabric over thecalf, strut and footplate 310; applying a layer of bidirectional carbonfiber fabric in the strut 320; placing a sheet of resin material 102,such as Ready Preg, around the calf, down the strut and around thefootplate 330; applying a 1″ g-braid around the calf and cut at thestrut 340; placing a 1″ g-braid 108 down the strut, around thefootplate, and back up to the back of the calf 350; applying a sheet ofresin 110 over all exposed g-braid 370; placing a layer of bidirectionalcarbon fiber fabric over the calf, strut and footplate 380; applying alayer of bidirectional carbon fiber fabric over the calf, strut andfootplate 390; wrapping the orthosis with clear plastic wrap about 3 to6 times 400; creating holes through the plastic wrap along the G-braidin the calf, strut and footplate 410; pulling a shear nylon stockinetover entire leg twice 420; pulling a thicker nylon stockinet over entireleg twice 430; moving leg to roto lam rack and pull a plastic bag overthe leg, sealing it so that it is air tight 440; placing the wrapped leginto a vacuum chamber oven 200, and turn on the vacuum, making sure thatthere are no air leaks 450; heating orthosis for approximately 4 hoursat about 250° F. 460; testing orthosis by applying pressure, such aswith thumb to make sure that orthosis is done and there are no softspots 470; pulling orthosis out of oven, pulling all layers of plasticand nylon stocking off of orthosis 480; breaking orthosis off of theplaster mold 490; smoothing or sanding orthosis down to the trim linesand rough up the outside surface 500; cleaning off all extra dust andmaterials with water 510; mixing two-part epoxy at about a 1 to 1 ration520; applying epoxy to clean orthosis let stand for about 24 hours 530;sanding down all extra epoxy 540; cutting out pads out of foam for thecalf and footplate 550; skiving calf edges and footplate next to theheel 560; sanding down all edges so that foam and carbon are level 570;and attaching a strap to the back of the calf
 580. 4. The method ofclaim 2, wherein said step of creating a molded plaster or fiberglasscast 100 is performed by creating a molded plaster or fiberglass cast 70in the shape of the feature of the patient's anatomy upon which theorthosis is intended to be used.
 5. The method of claim 4, wherein thepatient's anatomy is the lower portion of a patient's leg, including theankle and the foot.
 6. The method of claim 2, wherein the front tibiashell should be 3.5″ to 4″, the sides of orthosis should be about 3.5″wide, and the strut is about 2″ wide, and laying plaster bandage on thedrawn trim line
 190. 7. The method of claim 2, wherein step 230 furtherincludes pulling a cotton stockinet or similar material over the leg,then wrap leg with fiberglass wrap, let the wrap harden, then cut thewrap off of the leg mold.
 8. The method of claim 2, wherein the cuttingstep 250 is performed so that the foam is cut so that it does not coverany part of the strut.
 9. The method of claim 2, wherein the material inthe tracing step 290 is a piece of paper, to create a pattern that canbe used to cut layers of the orthosis to appropriate sizes, ensuring thenecessary amount of material is used in creating the orthosis,minimizing waste.
 10. The method of claim 3, wherein the bidirectionalcarbon fiber fabric is pre-impregnated with resin.
 11. The method ofclaim 3, wherein the unidirectional carbon fiber fabric is impregnatedwith resin.
 12. The method of claim 3, wherein the bidirectional carbonfiber fabric in the strut of the applying step 321 increases thestrength of the strut, and enhances the assist characteristics of theorthosis for both dorsiflexion and planar flexion.
 13. The method ofclaim 3, wherein in the applying step of 340 and the placing step of350, the g-braids increase the strength of the orthosis in the areasthat it is placed, and enhance the assist characteristics of theorthosis for both dorsiflexion and plantar flexion.
 14. The method ofclaim 3, wherein the applying step 370 is performed by making sure thatat least that most of the g-braid is covered with the sheet of resin110.
 15. An orthosis, comprising: a footplate (14) that is capable ofreceiving a human foot thereabove; a heel portion (30) at the rear sideof the footplate (14); a strut (16) extending upwardly from said heelportion (30); a calf portion (12) extending forwardly from said strut(16), said calf portion (12) including a tibial shell (18); said tibialshell (18) extends around the front of the user's tibia; a rear portion(20) extends around the back of the user's calf a rear portion (20)disposed rearwardly with respect to said calf portion (12); sides (22),(24) that extend along the sides of the user's leg, such that the calfportion (12) is completely circumferential without seams; said footplate14 extends under substantially all of the foot of the user, and includeslateral (26) and medial (28) flanges that extend upwardly on the sidesof the user's foot, and a heel portion (30) that extends upwardly aroundthe heel of the user's foot; said strut (16) extends between said calfportion (12) and said footplate (14), said strut (16) is a generallystraight strip of material that connects the heel portion (20) of thefootplate (14) to the sides (22), (24) of the calf portion (12); wherebythe orthosis (10) is capable of receiving a human lower leg and foottherein, the entire orthosis (10) is molded to a shape that iscustomized to the particular shape of the leg of a particular user. 16.The apparatus of claim 15, further comprising: a knee member (50)movably connected to said calf portion (12) via a joint (52).
 17. Theapparatus of claim 15, further comprising: a standard foam (72) disposedin the contactable area so that the user's skin contacts the standardfoam (72) during use and a reinforcing foam (70) disposed between thestandard foam (72) and at least one of said footplate (14), said heelportion, (30), said strut (16), said heel portion (30), said calfportion (12), or said tibial shell (18).